Ahead of the Bell: St. Jude migraine implant

NEW YORK (AP) — St. Jude Medical Inc. may have difficulty getting its implantable migraine treatment approved after the device did not meet its main goal in a clinical trial, an analyst said Friday.

The St. Paul, Minn., company is studying neurostimulation therapy as a treatment for migraines. In that type of therapy, patients are implanted with a device that sends electrical pulses to electrodes in the brain. The devices are used to treat chronic pain.

St. Jude said Thursday that its Genesis neurostimulation device, which works on the occipital nerve, reduced pain and days with headaches. But similar numbers of Genesis patients and placebo patients reported a 50 percent decrease in pain.

Because the improvement was not statistically significant, the study did not meet its primary goal. St. Jude said significantly more Genesis patients did report at least a 40 percent reduction in pain.

The company enrolled 157 patients in the trial. On average, they had headaches 26 days per month. During the 12 weeks of the study, St. Jude said patients who received the Genesis implant had seven fewer headache days per month, compared to one less day for the placebo group.

Morgan Keegan analyst Jan Wald said Genesis can reduce headaches, but the Food and Drug Administration may not approve it because of the study failure. He said not all the patients were happy with Genesis: 24 percent of them said they would not get the implant again, and 12 percent either would not recommend it to others, or were not sure they would recommend it.

St. Jude said 51 percent of the Genesis patients were satisfied with their headache relief and 67 percent reported an improvement in quality of life. In the placebo group, 19 percent of patients were satisfied with their headache relief and 17 percent said they quality of life had improved.

Wald said St. Jude may have used too many surveys and created too many different measurements in order to prove the implant works, as studies of drugs and devices that treat pain can be subject to interpretation.

"These trials are notoriously hard to design, and it seems that St. Jude overreached when it should have played a more conservative game," he wrote. He kept an "Outperform" on St. Jude shares.

St. Jude Medical stock fell 2.6 percent to $47.40 on Thursday. The shares have traded between $34.25 and $54.18 in the last year.